New Waived Tests - Centers for Medicare & Medicaid Services
New Waived Tests - Centers for Medicare & Medicaid Services
New Waived Tests - Centers for Medicare & Medicaid Services
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TESTS GRANTED WAIVED STATUS UNDER CLIA<br />
CPT CODE(S) TEST NAME MANUFACTURER USE<br />
82271QW,<br />
83986QW<br />
82274QW<br />
G0328QW<br />
82274QW<br />
G0328QW(cont.<br />
)<br />
Beckman Coulter Primary Care<br />
Diagnostics Gastrocult<br />
1. American IVD Biotechnology<br />
<strong>Services</strong> Inc. FOB/CRC<br />
Advanced+<br />
2. Beckman Coulter Hemoccult<br />
ICT (K961062) & (K080812)<br />
3. BTNX Inc. Know Fecal<br />
Occult Blood (FOB) Self Test<br />
4. BTNX Inc. Rapid Response<br />
Fecal Immunochemical Test<br />
(FIT)<br />
5. BTNX Inc. Rapid Response<br />
Immunological Fecal Occult<br />
Blood Test (IFOBT)<br />
6. BTNX Inc. Rapid Response<br />
Fecal Occult Blood (FOB)<br />
Self Test<br />
7. Care Diagnostics Clarity<br />
IFOB Test<br />
8. Clarity Hemosure One-Step<br />
Immunological Fecal Occult<br />
Blood Test<br />
Beckman Coulter, Inc.<br />
Ind Diagnostic Inc.<br />
Beckman Coulter, Inc.<br />
Alfa Scientific Designs,<br />
Inc.<br />
Ind Diagnostic Inc.<br />
Teco Diagnostics<br />
Alfa Scientific Designs,<br />
Inc<br />
Care Diagnostics, Inc.<br />
Wampole Laboratories<br />
9. Clearview Ultra FOB Test RAC Medical Group,<br />
Inc.<br />
Rapid screening test to detect the presence of gastric occult<br />
blood and determine the pH (acid-base balance) of gastric<br />
aspirates<br />
Detection of blood in feces from whatever cause, benign or<br />
malignant (colorectal cancer screening) by immunoassay<br />
Detection of blood in feces from whatever cause, benign or<br />
malignant (colorectal cancer screening) by immunoassay<br />
* <strong>New</strong>ly added waived test system 23
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